AB0590 GREATER STEROID-SPARING EFFECT OF TOCILIZUMAB THAN METHOTREXATE: A REAL-LIFE MONOCENTRIC EXPERIENCE
Authors: E. Treppo, M. Isola, M. De Martino, G. Del Frate, M. Binutti, S. De Vita, L. Quartuccio
Journal: Annals of the Rheumatic Diseases (2022)

Background Glucocorticoids (GCs) are still the mainstay of treatment of Giant Cell Arteritis (GCA), while Tocilizumab (TCZ) has been licensed as the first biologic treatment for GCA. Although GCs are highly effective in GCA, it is well documented the high burden of toxicity of GCs as well as the disease relapse during GC tapering. Therefore, patients with GCA may benefit from GC-sparing treatments[1]. Objectives The aim is to compare the efficacy as steroid-sparing agents of Tocilizumab (TCZ) or Methotrexate (MTX) in GCA. Methods A single-center retrospective study included 39 patients with newly diagnosed GCA confirmed by temporal artery biopsy, temporal artery ultrasound, or TC-PET. Patients were collected from December 2010 to December 2020. The inclusion criterion was the initiation of treatment with MTX or TCZ as GC-sparing agent within the first year of disease, whereas the exclusion criterion was previous treatment with other immunosuppressive agents. Results 11 patients received TCZ (162mg/week), while 28 patients MTX (up to 20mg/week) as a GC-sparing agent. Baseline characteristics were reported in Table 1. Table 1. Baseline characteristics of 39 newly diagnosed GCA patients. Median (IQR) or n (%) TCZ (n=11) MTX (n=28) All (n=39) P value Age, years 66 (57-77) 72 (66-76) 71 (65-76) 0.125 Female 9 (81.8) 20 (71.4) 29 (74.4) 0.504 ESR, mm/h 89.5 (71-116 ) 51.5 (39.5-88.5) 72 (46-92) 0.026 CRP, mg/L 102 (79-169 ) 43.9 (20.8-68) 54 (27-102) 0.006 Fibrinogen, mg/dL 605 (381-897) 680 (539-800) 680 (492-808) 0.760 ≥3 ACR criteria 5 (45.5) 10 (35.7) 15 (38.5) 0.718 AION 3 (27.3 ) 0 (0) 3 (0.8) 0.018 Fever 8 (72.7) 13 (46.4) 21 (53.8) 0.138 Extra-cranial symptoms 7 (63.6) 17 (60.7) 24 (61.5) 1.000 TAB positive 6 (54.5) 13 (46.4) 19 (48.7) 1.000 Halo sign positive 5 (45.5) 6 (21.4) 11 (28.2) 0.234 TC-PET positive 6 (54.5) 12 (42.9) 18 (46.2) 0.676 Comorbidities * 5 (45.5) 15 (53.6) 20 (51.3) 0.648 * Presence of at least one among diabetes mellitus, hypertension, ischaemic heart disease, obesity, or osteoporosis. The follow-up time between groups was 20 (IQR 18.5-24.5) months vs 36 (IQR 24-60.5) months, respectively. At the last medical examination, all patients were in sustained remission, 6/11 (54.5%) and 17/28 (60.7%) had discontinued GCs. The prednisone equivalent dosage of 5 mg/day was achieved at 5 (IQR 2.75-5.5) and 7 (IQR 5-10) months (p-value 0.078), respectively, while discontinuation of GCs was achieved at 7.5 (IQR 6.25-11) and 19 (IQR 14-24) months ( p-value 0.015 ), respectively. No differences were observed as concerns GC-related adverse events at 1 year after the onset of GCA (1 event in 11 patients [9.1%] vs 3 events in 28 patients [10.7%]). In details, GC-related adverse events were development of diabetes (2/4), hypertension (1/4), or osteoporosis (1/4). Two patients in the first group (18.2%) and 9 in the second one (32.1%) experienced at least one relapse (median time to relapse was 6.5 [IQR 5.75-7.25] and 18 [IQR 12-24] months). Relapses required the association of MTX with TCZ (1/11 [9.1%]) or start of TCZ (1/11 [9.1%] in the former group, while they required an increase in steroid dosage (7/11 [63.6%]), switch from MTX to TCZ (1/11 [9.1%]), or reinstatement of MTX therapy after its discontinuation (1/11 [9.1%]) in the latter. Overall, both drugs were well tolerated. 1/11 (9.1%) and 5/28 (17.9%) had discontinued TCZ and MTX, respectively, due to mild and reversible drug-related adverse events (4/6 general malaise or discomfort, 1/6 gastrointestinal symptoms, or 1/6 abnormal liver function tests). No serious infections were observed. Conclusion TCZ showed a faster steroid-sparing effect than MTX. Both immunosuppressants are safe, effective and allow the discontinuation of GCs. References [1]Quartuccio, L.; Isola, M.; Bruno, D.; Treppo, E.; Gigante, L.; Angelotti, F. et al. Treatment Strategy Introducing Immunosuppressive Drugs with Glucocorticoids Ab Initio or Very Early in Giant Cell Arteritis: A Multicenter Retrospective Controlled Study. J. Transl. Autoimmun. 2020 , 3 , 100072, doi:10.1016/j.jtauto.2020.100072. Disclosure of Interests None declared